Drug Delivery Devices And Related Systems And Methods

• US 20110004144A1
• Filed: 06/30/2010
• Published: 01/06/2011
• Est. Priority Date: 07/01/2009
• Status: Active Grant

• Current Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Original Assignee: Fresenius Medical Care Holdings Incorporated (Fresenius Medical Care AG)
• Inventors: Barron, John A. III, Beiriger, Michael James, Kaintz, Ryan
• Granted Patent: US 8,562,584 B2
• Time in Patent Office: Days
• US Class Current: 604/6.11
• CPC Class Codes: A61G 7/0503 Holders, support devices for receptacles, e.g. for drainage or urine bags hanging-up devices for infusion A61M5/1414
• CPC Class Codes: A61J 1/20 Arrangements for transferring or mixing fluids, e.g. from vial to syringe
• CPC Class Codes: A61J 1/201 having one piercing end
• CPC Class Codes: A61J 1/2013 having two piercing ends
• CPC Class Codes: A61J 1/2089 Containers or vials which are to be joined to each other in order to mix their contents combinations of vial and syringe for mixing their contents A61J1/2096
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61J 3/002 Compounding apparatus specially for enteral or parenteral nutritive solutions bottling liquids B67C
• CPC Class Codes: A61M 1/342 Adding solutions to the blood, e.g. substitution solutions for preventing coagulation A61M1/3672
• CPC Class Codes: A61M 1/3462 Circuits for the preparation thereof
• CPC Class Codes: A61M 1/3622 with a cassette forming partially or totally the blood circuit
• CPC Class Codes: A61M 1/36225 with blood pumping means or components thereof
• CPC Class Codes: A61M 1/36226 Constructional details of cassettes, e.g. specific details on material or shape
• CPC Class Codes: A61M 2005/3267 Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
• CPC Class Codes: A61M 2039/267 having a sealing sleeve around a tubular or solid stem portion of the connector
• CPC Class Codes: A61M 2205/12 with interchangeable cassettes forming partially or totally the fluid circuit
• CPC Class Codes: A61M 2205/14 Detection of the presence or absence of a tube, a connector or a container in an apparatus
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/583 by visual feedback
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 39/14 : for connecting tubes having sealed ends needle sets A61M5/162; having valves closing automatically on disconnection of line A61M39/26
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/1408 : in parallel, e.g. manifolds, sequencing valves access sites A61M39/02; tube connectors A61M39/10
• CPC Class Codes: A61M 5/1415 : Stands, brackets or the like for supporting infusion accessories
• CPC Class Codes: A61M 5/142 : Pressure infusion, e.g. using pumps
• CPC Class Codes: A61M 5/162 : Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube in jet-action syringes A61M5/30; connectors for tubes having sealed ends and a needle for piercing them A61M39/14
• CPC Class Codes: A61M 5/16827 : controlling delivery of multiple fluids, e.g. sequencing, mixing or via separate flow-paths infusion of multiple fluids without using a controller A61M5/1407
• CPC Class Codes: A61M 5/16831 : Monitoring, detecting, signalling or eliminating infusion flow anomalies low-level float-valves causing cut-off A61M5/40; indicating or recording presence, absence or direction of flow in general G01P13/0066
• CPC Class Codes: A61M 5/19 : having more than one chamber , e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly surgical glue applicators A61B17/00491
• CPC Class Codes: A61M 5/36 : with means for eliminating or preventing injection or infusion of air into body dialysis systems, blood oxygenators A61M1/14; haemofiltration equipment A61M1/34; automatic tube cut-off A61M39/281
• CPC Class Codes: G16H 20/17 : delivered via infusion or injection
• CPC Class Codes: G16H 20/40 : relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 : for local operation
• CPC Class Codes: Y02A 90/10 : Information and communication technologies [ICT] supporting adaptation to climate change, e.g. for weather forecasting or climate simulation

Abstract

This disclosure relates to drug delivery devices and related systems and methods. In some aspects, a drug delivery device includes a drug vial holder and a mechanism configured to compress a drug vial between upper and lower members of the drug vial holder.

Claims

1. A drug delivery device, comprising:

a drug vial holder comprising an upper member and a lower member, the upper and lower members being configured to receive a drug vial therebetween; and

a mechanism configured to move at least one of the upper and lower members relative to the other of the upper and lower members such that, when a drug vial is disposed between the upper and lower members and the at least one of the upper and lower members is moved toward the other, the drug vial is compressed between the upper and lower members.

2. The drug delivery device of claim 1, wherein the mechanism is configured to compress a seal disposed between a cap of the drug vial and a neck portion of the drug vial when the drug vial is disposed between the upper and lower members and the at least one of the upper and lower members is moved toward the other.

3. The drug delivery device of claim 1, wherein a plurality of projections extend from a surface of the lower member, the projections being configured to dent adjacent portions of a cap of the drug vial into a seal of the drug vial when the drug vial is compressed between the upper and lower members.

4. The drug delivery device of claim 3, wherein the projections are configured to pierce the adjacent portions of the cap of the drug vial when the drug vial is compressed between the upper and lower members.

5. The drug delivery device of claim 1, wherein the lower member defines an opening sized to receive a drug vial spike, and the opening is arranged to align with a seal of the drug vial when the drug vial is disposed between the upper and lower members.

6. The drug delivery device of claim 1, wherein the lower member defines a recess configured to receive a portion of the drug vial therein.

7. The drug delivery device of claim 1, wherein the mechanism is configured to move the upper member, the lower member, and the drug vial disposed therebetween in unison after compressing the drug vial between the upper and lower members.

8. The drug delivery device of claim 1, wherein the mechanism comprises a motor that, when operated, causes the at least one of the upper and lower members to move toward the other.

9. The drug delivery device of claim 8, wherein the mechanism is configured in a manner such that, after operating the motor for a period of time to compress the drug vial between the upper and lower members, continued operation of the motor causes the upper and lower members to move in unison.

10. The drug delivery device of claim 1, wherein the mechanism is configured to move the upper member of the drug vial holder toward the lower member of the drug vial holder.

11. The drug delivery device of claim 1, wherein the mechanism comprises a rotatable, threaded drive shaft to which a threaded drive member is secured, and the drive member is configured such that rotation of the drive shaft causes the drive member to move axially along the drive shaft.

12. The drug delivery device of claim 11, wherein the drive member comprises a ball screw.

13. The drug delivery device of claim 11, wherein the drive member is secured to the upper member of the vial holder in a manner such that axial movement of the drive member causes axial movement of the upper member.

14. The drug delivery device of claim 13, wherein the drive member is secured to a cross bar that is attached to at least one extension member, and the at least one extension member is attached to the upper member of the drug vial holder.

15. The drug delivery device of claim 1, wherein the mechanism comprises at least one resilient member configured to resist downward movement of the lower member of the drug vial holder.

16. The drug delivery device of claim 15, wherein the at least one resilient member comprises a spring.

17. The drug delivery device of claim 15, wherein the at least one resilient member is configured to provide sufficient resistance to downward movement of the lower member to cause a seal of a drug vial disposed between the upper and lower members to be compressed when the at least one of the upper and lower members is moved toward the other.

18. The drug delivery device of claim 17, wherein the at least one resilient member is configured to collapse and allow the drug vial to move in unison with the upper and lower members after the seal of the drug vial has been compressed.

19. The drug delivery device of claim 1, further comprising at least one spike disposed beneath the drug vial holder, wherein the mechanism is configured to move the upper and lower members of the drug vial holder in unison relative to the spike to cause the spike to penetrate a drug vial disposed between the upper and lower members.

20. The drug delivery device of claim 1, further comprising a pump configured to be operably connected to a fluid line that is in fluid communication with a drug vial disposed between the upper and lower members of the drug vial holder such that operation of the pump can draw drug from the drug vial and through the fluid line.

21. The drug delivery device of claim 1, wherein the mechanism is manually operable.

22. A drug delivery system, comprising:

a drug delivery device comprising

a drug vial holder comprising an upper member and a lower member; and

a mechanism connected to the drug vial holder; and

a drug vial disposed between the upper and lower members of the drug vial holder,

wherein the mechanism is configured to move at least one of the upper and lower members relative to the other of the upper and lower members in a manner to compress the drug vial therebetween.

23. The drug delivery system of claim 22, wherein the mechanism is configured to compress a seal disposed between a cap of the drug vial and a neck portion of the drug vial when the at least one of the upper and lower members is moved toward the other.

24. The drug delivery system of claim 22, wherein a plurality of projections extend from a surface of the lower member, the projections being configured to dent adjacent portions of a cap of the drug vial into a seal of the drug vial when the drug vial is compressed between the upper and lower members.

25. The drug delivery system of claim 22, wherein the mechanism is configured to move the upper member, the lower member, and the drug vial disposed therebetween in unison after compressing the drug vial between the upper and lower members.

26. The drug delivery system of claim 22, wherein the mechanism is configured to move the upper member of the drug vial holder toward the lower member of the drug vial holder.

27. The drug delivery system of claim 22, further comprising a spike disposed beneath the drug vial holder, wherein the mechanism is configured to move the upper and lower members of the drug vial holder in unison relative to the spike to cause the spike to penetrate a drug vial disposed between the upper and lower members.

28. The drug delivery system of claim 22, further comprising a pump configured to be operably connected to a fluid line that is in fluid communication with the drug vial disposed between the upper and lower members of the drug vial holder such that operation of the pump can draw drug from the drug vial and through the fluid line.

29. A dialysis system, comprising:

a dialysis machine comprising

a blood pump;

a drug delivery device comprising

a drug pump;

a drug vial holder comprising an upper member and a lower member; and

a mechanism configured to move at least one of the upper and lower members relative to the other of the upper and lower members such that, when a drug vial is disposed between the upper and lower members and the at least one of the upper and lower members is moved toward the other, the drug vial is compressed between the upper and lower members;

a blood line set comprising a blood line that is operably connected to the blood pump; and

a fluid line set comprising a fluid line that is operably connected to the drug pump and is connected to a spike, the fluid line set being configured such that the spike can be placed in fluid communication with the drug vial retained between the upper and lower members of the drug vial holder by moving the drug vial holder and the drug vial relative to the spike, wherein the fluid line is in fluid communication with the blood line set such that a drug can be delivered from the drug vial to the blood line set when the drug pump is operated.

30. A method, comprising:

inserting a spike through a seal of a drug vial to allow fluid communication between an interior of the drug vial and a channel defined by the spike; and

deforming a portion of the seal away from a body of the drug vial to facilitate removal of drug from the interior of the drug vial, wherein deforming the portion of the seal away from the body of the drug vial comprises using a mechanism to move the spike relative to the drug vial.

31. The method of claim 30, wherein the seal is a rubber seal.

32. The method of claim 30, wherein deforming the portion of the seal comprises using the spike to apply a force to the portion of the seal.

33. The method of claim 32, wherein the force is a frictional force.

34. The method of claim 33, wherein moving the spike relative to the vial comprises applying a force to the body of the drug vial in a direction opposite the force applied to the portion of the seal.

35. The method of claim 30, further comprising maintaining the seal in a compressed state while inserting the spike through the seal.

36. The method of claim 35, wherein the seal is compressed between a cap of the drug vial and a neck portion of the drug vial.

37. The method of claim 35, wherein the seal is compressed between a cap of the drug vial and a body portion of the drug vial.

38. The method of claim 30, wherein the mechanism comprises a spring.

39. The method of claim 30, wherein the mechanism is an automated mechanism.

40. A method, comprising:

compressing a seal of a drug vial between a cap of the drug vial and a neck portion or body portion of the drug vial by disposing the drug vial between an upper member and a lower member of a drug vial holder and moving at least one of the upper and lower members of the drug vial holder toward the other of the upper and lower members of the drug vial holder; and

while maintaining the seal in a compressed state, inserting a spike through the seal of the drug vial to allow fluid communication between an interior of the drug vial and a channel defined by the spike.

41. The method of claim 40, wherein the seal is compressed between a cap of the drug vial and a neck portion of the drug vial.

42. The method of claim 40, wherein the seal is a rubber seal.

43. The method of claim 40, further comprising denting portions of the cap into the seal.

44. The method of claim 43, wherein denting the portions of the cap into the seal comprises forcing the cap against projections extending from a surface of the lower member of the drug vial holder.

45. The method of claim 43, wherein denting the portions of the cap into the seal comprises piercing portions of the cap.

46. The method of claim 40, further comprising deforming a portion of the seal away from a body of the drug vial to facilitate removal of drug from the drug vial.

47. The method of claim 46, wherein deforming the portion of the seal comprises using the spike to apply a force to the portion of the seal.

48. The method of claim 47, wherein the force is a frictional force.

49. The method of claim 48, further comprising applying a force to the body portion of the drug vial in a direction opposite the force applied to the portion of the seal.

50. The method of claim 48, further comprising applying a force to the neck portion of the drug vial in a direction opposite the force applied to the portion of the seal.